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53. Frage
XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you are conducting a certification audit at Stage 1. When reviewing the quality management system (QMS) documentation, you find that quality objectives have been set for every employee in the organisation except top management. The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive is asking questions about how much it will cost. He asks for your opinion on whether this is the correct method of setting objectives.
How would you respond with the following options? Select three.
Antwort: A,C,H
Begründung:
According to the ISO 9001:2015 standard, clause 6.2.1 requires organizations to establish quality objectives at relevant functions, levels, and processes needed for the quality management system. The quality objectives must be consistent with the quality policy and the strategic direction of the organization. The quality objectives must also be measurable, monitored, communicated, and updated as appropriate.
In this scenario, the Quality Manager of XYZ Corporation has set quality objectives for every employee in the organization except top management. This has created a lot of resistance to the QMS, and the Chief Executive is asking questions about the cost and the method of setting objectives. The Quality Manager asks for your opinion as an auditor on whether this is the correct method of setting objectives.
As an auditor, you cannot provide advice to the organization on how it should operate its QMS. Your role is to assess the conformity and effectiveness of the QMS against the requirements of the standard and the organization's own policies and objectives. Therefore, you should respond with the following options:
B: Advise the Quality Manager to read the ISO 9001 standard and interpret in relation to the organization's requirements: You can suggest that the Quality Manager should familiarize himself with the requirements of clause 6.2.1 and understand how they apply to his organization. He should also consider the context and the needs and expectations of interested parties when setting quality objectives. He should ensure that the quality objectives are aligned with the quality policy and the strategic direction of the organization.
C: Advise the Quality Manager that you will raise an opportunity for improvement if the quality objectives are not addressed properly: You can inform the Quality Manager that you will evaluate the quality objectives during the audit and check whether they meet the requirements of clause 6.2.1. If you find any gaps or weaknesses in the quality objectives, you will raise an opportunity for improvement to help the organization improve its QMS. You will also verify whether the quality objectives are monitored, communicated, and updated as appropriate.
D: Inform the Quality Manager that you will comment on the subject in your audit report: You can inform the Quality Manager that you will document your findings and observations on the quality objectives in your audit report. You will also provide a summary of the audit results and any recommendations for improvement.
You will also indicate the level of conformity and effectiveness of the QMS.
These three options would help you to maintain your impartiality and professionalism as an auditor and to provide constructive feedback to the organization
54. Frage
Scenario 4:
TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.
To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.
After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.
Anne reviewed the document and approved the audit mandate. The certification body and TD's top management signed the certification agreement.
Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.
In scenario 4, the audit team determined the audit feasibility by considering only the resources available for the audit. Is this acceptable?
Antwort: A
Begründung:
Comprehensive and Detailed In-Depth Explanation:
An audit's feasibility must be assessed using multiple factors, not just resource availability.
Clause References:
* ISO 19011:2018, Clause 5.3 - Establishing the Audit Program: Requires consideration of logistical, technical, and cooperation factors when assessing audit feasibility.
* ISO/IEC 17021-1:2015, Clause 9.1.3 - Determining Feasibility of the Audit: Requires evaluating more than just resources to ensure a successful audit.
Why is the Correct Answer B?
* Audit feasibility should consider:
* Availability of information (documents, records).
* Cooperation from the auditee.
* Operational conditions that might affect the audit.
* Scope and complexity of the QMS being audited.
* Resource availability alone is not enough to determine feasibility.
Why are the Other Options Incorrect?
* A (Top management determines feasibility) # Incorrect because feasibility is determined by the certification body, not the auditee.
* C (Resources alone are sufficient) # Incorrect because other key factors must be evaluated.
* D (Final authority lies with the audit leader) # Incorrect because ISO requires multiple factors to be considered, not just an auditor's decision.
55. Frage
What type of audit evidence are policies and guidelines?
Antwort: B
Begründung:
Comprehensive and Detailed In-Depth Explanation:
Policies and guidelines are considered documentary evidence because they are written records that demonstrate how an organization complies with ISO 9001 requirements.
Clause References:
* ISO 19011:2018, Clause 6.4.6 - Audit Evidence:
* Documentary evidence includes manuals, procedures, and policies.
Why is the Correct Answer C?
* Documentary evidence includes written records such as policies, procedures, and documented instructions that support QMS implementation.
* Auditors review policies to verify conformance with ISO 9001.
Why are the Other Options Incorrect?
* A (Confirmative evidence) # Not a recognized category in ISO auditing.
* B (Technical evidence) # Technical evidence refers to measurements, test results, or product data, not policies.
Reference:
ISO 19011:2018, Clause 6.4.6 - Audit Evidence
56. Frage
Match the process descriptions below to the process names:
Antwort:
Begründung:
Explanation:
Match the process descriptions below to the process names:
The process by which the accuracy of test equipment is checked against a known standard. = Calibration The process by which a product or service is visually examined to determine conformity to requirements. = Evaluation The process by which data is examined in detail to reach a specific answer or answers. = Analysis The process by which a parameter of a product or service is examined to determine a specific value. = Measurement According to the ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary, the definitions of the process names are as follows:
Calibration: operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication.
Evaluation: determination of the suitability, adequacy or effectiveness of an object to achieve established objectives.
Analysis: detailed examination of the elements or structure of something.
Measurement: process to experimentally obtain one or more quantity values that can reasonably be attributed to a quantity.
Therefore, the process descriptions can be matched to the process names based on these definitions.
References:
ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary
57. Frage
State the correct sequence of events in the certification process for an organisation to obtain third-party accredited certification to ISO 9001.
Antwort:
Begründung:
58. Frage
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